Regulatory Affairs Manager

  • cardinal health
  • Mansfield, MA, USA
  • Aug 01, 2020
Full time Government

Job Description

What does Regulatory Affairs contribute to Cardinal Health?

The Regulatory Manager is responsible for the support of new product development and maintenance of business projects. Specific responsibilities include but are not limited to:

  • Support new product development/modifications projects to establish and integrate regulatory submission strategies into project activities.
  • Regulatory Subject Matter Expert for the assigned projects and for applicable manufacturing sites, regarding design, development, validation, commercialization of products throughout the product life cycle.
  • Prepare submissions (ie., Premarket Approvals: US Class III (PMA) and 510(k), CE marking Applications, Technical documentation, etc.) to obtain domestic filings, European regulatory approvals, and maintain existing approvals through periodic reporting, supplements/notices, Letters to File, renewals, change notifications, etc.
  • In collaboration with International Regulatory Affairs, determine applicable registration requirements and assist with STED preparation for medical devices for countries in which products are to be registered.
  • Interpret and/or evaluate proposed registration requirements for medical devices and advise on the impact of such regulations to the company.
  • Review and approve device labeling and advertising materials for compliance with regulations and product filings.
  • Maintain regulatory intelligence through continuous monitoring of regulatory landscape; identify risks, mitigation, and resolution strategies.
  • Evaluate, develop, implement business process improvements.

Essential Functions:

  • Strong knowledge of FDA regulations, EU regulations
  • Working knowledge of IEC 60601.
  • Interface with other functional departments to influence efficient execution of projects and provide regulatory support to project teams.
  • Compile and maintain regulatory filings (i.e., Product submissions).
  • Review change control documents and ascertain regulatory impact.
  • Monitor regulatory landscape.
  • Interface with FDA and Notified Body as required

Department Specific/Essential Functions:

  • Effective project management skills.
  • Ability to create cross-functional partnerships.
  • Effective negotiation skills.
  • Ability to work collaboratively in a team environment.
  • Effective oral and written communication skills.
  • Effective problem-solving skills.
  • Critical Thinker.

Minimum Requirements:

Education:

  • Bachelor's Degree required.

Experience:

  • 8+ years Regulatory experience or equivalent required.
  • Majority of Regulatory experience in Medical Device is preferred.
  • US Class III (PMA) experience is required.
  • Experience interacting with Regulatory Agencies.

Language:

  • Fluent in local language is required.

What is expected of you and others at this level

  • Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
  • Participates in the development of policies and procedures to achieve specific goals
  • Recommends new practices, processes, metrics, or models
  • Works on or may lead complex projects of large scope
  • Projects may have significant and long-term impact
  • Provides solutions which may set precedent
  • Independently determines method for completion of new projects
  • Receives guidance on overall project objectives
  • Acts as a mentor to less experienced colleagues

This is a remote / work from home position with 10-25% travel required.

Cardinal Health is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.